| NCT ID | NCT06999577 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Diego |
| Condition | Laryngopharyngeal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2025-06-04 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients. The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants? If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups. Participants will be be asked to do the following: * participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy * take an oral capsule daily (omeprazole 40mg or placebo) * come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider * consider incorporating recommended lifestyle modifications * complete weekly surveys
Eligibility Criteria
Inclusion Criteria: 1. 18-89 years of age 2. \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia) 3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression 4. Off acid suppression therapy for at least 2 weeks prior to randomization. Exclusion Criteria: 1. PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles 2. History of foregut surgery 3. Known diagnosis of achalasia 4. Inability to fast for 4 hours (no food or drink) 5. Active tobacco use 6. Pregnant or breastfeeding 7. Unable to consent in English or Spanish 8. Unable to provide consent without a legal guardian or representative 9. Imprisoned 10. Endoscopic findings conclusive with esophageal mucosal abnormalities 11. Unable to proceed with reflux monitoring 12. Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed 13. Prior LRT for reflux related symptoms 14. History of major psychiatric comorbidity 15. Unable to attend in person study visits at UCSD
Contact & Investigator
Rena Yadlapati, MD
PRINCIPAL INVESTIGATOR
UC San Diego Health
Frequently Asked Questions
Who can join the NCT06999577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Laryngopharyngeal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06999577 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06999577 currently recruiting?
Yes, NCT06999577 is actively recruiting participants. Contact the research team at esophagealresearch@health.ucsd.edu for enrollment information.
Where is the NCT06999577 trial being conducted?
This trial is being conducted at San Deigo, United States.
Who is sponsoring the NCT06999577 clinical trial?
NCT06999577 is sponsored by University of California, San Diego. The principal investigator is Rena Yadlapati, MD at UC San Diego Health. The trial plans to enroll 160 participants.